Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

NCT06479161 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SFH 24-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) Pain scores

  Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.

  postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).

Secondary Outcomes (3)

• Range of Motion

  at 2, 6 and 12 week follow up visits

• Opioid consumption

  POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)

• Ambulation Status

  at 2, 6 and 12 week follow up visits

Study Arms (2)

TXA

ACTIVE COMPARATOR

\- 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

\- 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

1.95 grams oral

Placebo; TXA

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
• Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
• Male and female patient age 18-89
• Primary diagnosis of knee osteoarthritis

You may not qualify if:

• Revision TKA
• Patients \<18 and \>89 years old
• TXA allergy - there are NO absolute contraindications for TXA use.
• History of stent placed within one year of surgery - patient will receive topical TXA as an alternative.
• o Actively treated cancer or deep vein thrombosis (DVT)
• Chronic opioid use (opioid use within the 4 weeks prior to surgery)
• Allergies to nonsteroidal Anti-inflammatory drugs (NSAIDs) and acetaminophen
• Patients with clinically significant drug interactions
• Pre-existing neuropathy
• Current or previous venous thrombosis (DVT or venous stasis disease)
• Immuno-compromised secondary to medical condition
• Immune-suppressive medications, chemotherapy
• Pregnancy, breast feeding
• History of pain catastrophizing. Major depressive disorder
• History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

Sponsors & Collaborators

• Matthew Grosso, MD: lead

Study Sites (1)

Trinity Health Of New England/CT Joint Replacement Institute

Hartford, Connecticut, 06105, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Gina Panek, BS

CONTACT

860-714-4164; gpanek@trinityhealthofne.org

Czarina Weinz

CONTACT

860-714-0467; Czarina.Weinz@trinityhealthofne.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This will be a double blinded study, with both patient and surgeon blinded to study group. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Quality and Outcomes Research

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 28, 2024
• Study Start: June 10, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)